Full Press Release Details
Weism llerstrasse 50
60314 Frankfurt am Main
Yakult Honsha Co., Ltd.
1-19 Higashi Shimbashi 1-chome
[***] = Portions of this exhibit have been omitted pursuant to a confidential treatment request in accordance with Rule 24b-2 under the Securities Exchange Act of 1934. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission.
| 1. | Definitions | 3 |
| 2. | Grant and Scope of License | 8 |
| 3. | Licensee s Obligations | 9 |
| 4. | Licensor s Obligations | 11 |
| 5. | Payments and Royalties | 12 |
| 6 . | Development Work, Steering Committee | 16 |
| 7 . | Use of Development Data | 18 |
| 8 . | Improvements | 18 |
| 9 . | Supply of Perifosine | 20 |
| 10 . | Licensor Patent Rights | 22 |
| 1 1 . | Infringement and Third Party Licenses | 24 |
| 12. | Joint Patent Rights to Joint Results | 24 |
| 13. | Trademarks | 25 |
| 14. | Exchange of Safety Information | 26 |
| 15 . | Confidentiality Information | 26 |
| 16 . | Warranties and Liabilities | 29 |
| 17 . | Indemnification and Insurance | 30 |
| 18 . | Term and Termination | 33 |
| 19 . | Consequences of Termination | 34 |
| 20 . | General Provisions | 35 |
WHEREAS, Licensor is the owner of or controls certain patent rights and know how relating to a compound known as Perifosine; and
WHEREAS, Licensee desires to obtain certain licenses from Licensor to further develop and commercialize Perifosine under the aforesaid patent rights and know how, and Licensor is willing to grant to Licensee such licenses.
NOW, THEREFORE, in consideration of the mutual covenants and obligations set forth below, the Parties agree as follows:
For purposes of this Agreement, the following terms shall have the following meanings:
1.1 Affiliate shall mean and include in relation to each Party, any person, firm, corporation or other entity: (i) if at least fifty percent (50%) of the voting stock or other equity interest thereof is owned, directly or indirectly, by that Party; (ii) which owns, directly or indirectly, at least fifty percent (50%) of the voting stock or other equity interest of that Party; or (iii) if at least fifty percent (50%) of the voting stock or other equity interest thereof is owned, directly or indirectly, by a person, firm, corporation or other entity that owns, directly or indirectly, at least fifty percent (50%) of the voting stock or other equity interest of that Party.
1.2 Agreement shall mean this Agreement and all Exhibits attached hereto, and the terms herein , hereunder , hereto and such similar expressions shall refer to this Agreement.
1.3 Calendar Quarter shall mean each respective period of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect.
1.4 CMC shall mean Chemistry, Manufacturing and Controls and refers to the regulatory term under the applicable laws and/or regulations applicable to Manufacturing and Development. CMC Activities as used in this Agreement refers to relevant development activities for the Manufacturing.
1.5 Commercialization shall mean any and all activities directed to the marketing, promotion, distribution, offering for sale and selling a Licensed Product, and shall include any and all pre-launch and post-launch marketing, detailing, marketing research, packaging, labeling, importing, exporting and transporting the Licensed Products for commercial sale and regulatory affairs. Commercializing , Commercialize and Commercialized shall have corresponding meanings.
1.6 Commercially Reasonable Efforts shall mean a level of resources, efforts and urgency to develop, manufacture, commercialize the Licensed Products applied by a Party that is consistent with such Party s usual practices in actively pursuing the development, manufacturing and commercialization of a pharmaceutical product owned or controlled by it at a similar stage of product life, taking into account competing products, market demand, proprietary position of the product, regulatory and reimbursement status, and other relevant technical, legal, scientific, safety, medical or regulatory factors.
1.7 Confidential Information shall mean and include all know how including the Licensor Know How, data including the Development Data and information including proprietary information and materials, not in the public domain, relating to Perifosine, the Licensed Products, or the business, affairs, research and development activities, CMC Activities, results of non-clinical studies and clinical trials, national and multinational regulatory proceedings and affairs, finances, plans, contractual relationships and operations of the Parties. The terms and conditions of this Agreement shall be considered as Confidential Information of both Parties.
1.8 Control or Controlled shall mean, with respect to the subject item, the possession by a party of the right (whether by ownership, license or otherwise) to grant to any other parties access or a license as provided herein.
1.9 CRC shall mean colorectal cancer.
1.10 Development shall mean all non-clinical and clinical research and drug development activities conducted in respect of Perifosine and/or a Licensed Products, including those necessary to obtain Regulatory Approval. Development shall include, without limitation, CMC Activities, non-clinical testing, test method development and stability testing, toxicology, pharmacokinetics, pharmacological and pharmacoeconomic studies, mechanism studies, formulation development, delivery system development, quality assurance, clinical studies, regulatory affairs and activities, statistical analysis and report writing of submission documents. Develop , Developed and Developing shall have a corresponding meaning.
1.11 Development Data shall mean reports of clinical studies and other documentation containing or embodying any pre-clinical, clinical and/or CMC data relating to the application for Regulatory Approval for the Licensed Products and/or Perifosine or the use of Perifosine and/or Licensed Products in the Field, including, but not limited to, registration dossiers.
1.12 Development Plan shall mean the plan describing the Development activities for obtaining Regulatory Approval in the Field in the Territory and setting forth timelines to achieve such activities (as set forth in Section 6). An outline of the initial Development Plan ( Outline of Development Plan ) is attached as Exhibit 1.12.
1.13 Effective Date shall mean the date stipulated in the closing paragraph of this Agreement on which this Agreement is executed by the duly authorized representatives of each of the Parties.
1.14 Field shall mean all human uses of Perifosine and/or Licensed Products, provided, however, the Field shall not include any use for the indication with respect to Leishmaniasis.
1.15 First Commercial Sale shall mean, the first sale by Licensee or its Affiliates, sublicensees or distributors of any of the Licensed Products in the Field in the Territory, after having obtained all of the applicable Regulatory Approvals.
1.16 Generic Products shall mean products other than Licensed Products approved for sale in the Field and in the Territory that contain Perifosine as an active ingredient.
1.17 Improvement(s) shall mean and include any and all Inventions, and any and all changes, modifications and amendments regarding Perifosine and/or Licensed Products, whether patentable or not, which: (i) improve the performance, usability or efficacy of Perifosine and/or Licensed Products; (ii) reduce any side effects, drug interactions or other adverse effects of Perifosine and/or Licensed Products; or (iii) reduce the cost and/or increase the efficiency or productivity of the Manufacturing.
1.18 Invention(s) shall mean and include any and all inventions and discoveries which are, or may be, patentable or otherwise protectable under the patent or other intellectual property laws of any country, which relate to Perifosine and/or Licensed Products, and which are conceived, discovered or reduced to practice during the continuance of this Agreement.
1.19 Licensed Products shall mean and include all pharmaceutical products, whether as mono-preparations or combination-preparations, containing Perifosine as an active ingredient, for use in the Field, in any form of administration whatsoever, which are subject to the licenses under this Agreement.
1.20 Licensor Know How shall mean and include, with respect to Perifosine and/or Licensed Products, all specifications, results of non-clinical studies and clinical trials, Development Data, technical data and other information relating to the design, formulation, manufacture, production, quality control, Regulatory Approvals, distribution, sale and/or use of Perifosine and/ or Licensed Products in the Field, to which Licensor has rights as of the Effective Date. Where Controlled by Licensor, the Licensor Know How shall extend to know how of Licensor s Affiliates and Licensor s Other Licensees relating to Perifosine. Without limiting the generality of the definition set forth in this Section 1.20, the Licensor Know How as of the Effective Date is described in more detail in Exhibit 1.20 hereto.
1.21 Licensor s Other Licensees shall mean non-Affiliate licensees appointed by Licensor outside the Territory.
1.22 Licensor Patent Rights shall mean Patents Rights, that are Controlled by Licensor as of the Effective Date and/or during the term of this Agreement in the Territory. Without limiting the generality of the definition set forth in this Section 1.22, the Licensor Patent Rights existing as of the Effective Date are listed in more detail in Exhibit 1.22 hereto.
1.23 Manufacturing shall mean to process, prepare, make or have made, manufacture or have manufactured and analyze Perifosine and/or Licensed Products, and shall include without limitation the synthesis of Perifosine and the conversion of Perifosine into Licensed Products, formulation and all subsequent packaging and labeling, quality control, process validations and other testing steps. Manufacture and Manufactured shall have a corresponding meaning.
1.24 Marketing Authorization shall mean the approval by a Regulatory Authority for the commercial sale and/or use of a Licensed Product.
1.25 Marketing Authorization Application or MAA shall mean the application for Marketing Authorization to be filed with the relevant Regulatory Authority, including any new drug application (NDA) for the Territory, and any other application for Marketing Authorization to be filed with the MHLW.
1.26 MHLW shall mean Japan s Ministry of Health, Labor and Welfare and any of its subsidiary agencies or local governments responsible for pharmaceutical matters, or any successor agency having substantially the same function.
1.27 MM shall mean multiple myeloma.
1.28 Net Sales shall mean the amount invoiced by Licensee, its Affiliates, its sublicensees or distributors on account of sales of Licensed Products to Third Parties in the Territory, less the following deductions to the extent actually allowed or specifically allocated to the Licensed Product by the selling party using generally accepted accounting standards:
(i) [******************************(1)];
(ii) [******************************];
(iii) [******************************];
(iv) [******************************].
For the avoidance of doubt, for each Licensed Product the Net Sales shall be calculated only once for the first sale of such Licensed Product by either Licensee, its Affiliate, its sublicensee or its distributor, as the case may be, to a Third Party which is neither an Affiliate, sublicensee or distributor of Licensee. A sale of Licensed Products by Licensee, its Affiliate, its sublicensee or its distributor to a wholesaler shall be regarded as the first sale of the Licensed Product for the purpose of calculating Net Sales.
1.29 NHI Drug Price shall mean the price of a pharmaceutical product listed on the drug price of the Japanese National Health Insurance.
(1) Exclusion of confidential and/or competitively sensitive information relating to the Licensor, the Licensee or certain terms of the License Agreement. Omitted information is the subject of a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been filed separately with the Securities and Exchange Commission.
1.30 Party or Parties shall mean Licensee or Licensor, or Licensee and Licensor, as the context admits.
1.31 Patent Rights shall mean any and all (i) patents, and (ii) patent applications, including without limitation, all provisional applications, divisions, continuations, continuation-in-part applications, divisionals, extensions, substitutions, renewals, confirmations, supplementary protection certificates or equivalent thereof, reexaminations and reissues that are relating to, embodied in, or associated with Perifosine and/or Licensed Products.
1.32 Perifosine shall mean Perifosine described in Exhibit 1.32 hereto and any salts of such compound.
1.33 Regulatory Approvals shall mean and include all licenses, permits, authorizations including Marketing Authorization and approvals of, and all registrations, filings and other notifications to, any governmental agency or department, necessary or appropriate for the manufacture, production, distribution, marketing, sale and/or use of Perifosine and/or Licensed Products within the Field.
1.34 Regulatory Authorities shall mean any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity involved in the granting of Regulatory Approvals, including, without limitation, the MHLW.
1.35 Territory shall mean and include Japan.
1.36 Third Indication shall mean any third indication other than CRC and MM in the Field.
1.37 Third Party shall mean any other party that is independent from Licensee and its Affiliates and Licensor and its Affiliates.
1.38 Trials Product shall have the meaning set out in Section 9.1.1
1.39 Valid Claim shall mean (i) any claim of an issued and unexpired Licensor Patent Right, which has not been held unenforceable or invalid by a court or other governmental agency of competent jurisdiction in a decision that is not appealed or cannot be appealed, and which has not been disclaimed or admitted to be invalid or unenforceable through reissue or otherwise, or (ii) a pending claim in a pending patent application within the Licensor Patent Rights. Notwithstanding the foregoing clause (i), in the event that a pending claim in a pending application does not issue as a valid and enforceable claim in an issued patent within five (5) years after the earliest date from which such patent application claims priority, such a pending claim will not be a Valid Claim, unless and until such pending claim subsequently issues as a valid and enforceable claim in an issued patent, in which case such claim will be reinstated and be deemed to be a Valid Claim as of the date of issuance of such patent.
2. Grant and Scope of License
2.1 Licensor hereby grants to Licensee, and Licensee hereby accepts an exclusive (even as to Licensor) license as of the Effective Date to use the Licensor Patent Rights and the Licensor Know How to (i) Develop, have Developed, Commercialize, and have Commercialized Perifosine and/or Licensed Products in the Field in the Territory;(ii) worldwide (except for USA, Canada, Mexico and Korea) Manufacture and have Manufactured for the Territory, obtain and import Perifosine and/or Licensed Products for the Territory, subject to the supply provisions under Section 9.3 below; and, (iii) obtain, maintain and hold Regulatory Approvals in the Territory, in accordance with the terms and conditions, and subject to the limitations of this Agreement. [*******************************************(2)]
2.2 Licensee shall be entitled to sublicense all or any of its rights under this Agreement to any Affiliate and, only upon Licensor s prior written consent which shall not be unreasonably withheld, to any Third Party without any additional participation payment to Licensor. In case Licensee grants sublicenses hereunder, Licensee always shall secure appropriate covenants, obligations and rights from any such sublicensee so as to ensure that such sublicensee is also able to comply with Licensee s covenants and obligations hereunder to the extent that Licensee shall not be performing such covenants and obligations. Licensee shall provide to Licensor a reasonably redacted copy of the sublicense agreement concluded with such sublicensee. Licensor acknowledges that all and any information provided by Licensee to Licensor under this Section 2.2 will be deemed to be Confidential Information of Licensee and will be subject to the terms of Section 15. For clarity, Licensee may subcontract its task or works under this Agreement to CROs, CMOs, and/or CSOs, and such subcontract shall not be subject to Licensee s obligation for providing Licensor with the sublicense agreement mentioned above.
2.3 In connection with Licensee s exclusive rights under Section 2.1, in the case that Licensor and/or its Affiliates wish to use Licensor Patent Rights and/or Licensor Know How for the purpose of carrying out by itself or through a Third Party such as a university, a contract research organization or a non-profit organization (provided that appropriate material transfer agreement with such Third Party is in place) any further non-commercial exploratory work relating to Perifosine inside the Territory, Licensor shall consult and discuss with Licensee on details of such exploratory work including potential participation of Licensee therein and terms and conditions of the material transfer agreement in advance of conducting such exploratory work.
2.4 In furtherance of the rights and licenses granted by Licensor to Licensee under this Agreement, within [***** **** ****] after the Effective Date of this Agreement Licensor shall furnish to Licensee a data package that shall include all of the Licensor Know How. Licensee shall not use any of the Licensor Know How furnished by Licensor under this Section 2.4 for any purpose whatsoever, except as specifically authorized in this Agreement, or as otherwise specifically authorized in writing by Licensor. In the event that Licensee reasonably believes that the Licensor Know How included in the data package furnished by Licensor under this Section 2.4 is incomplete, Licensee shall provide written notice thereof to Licensor, and Licensor
(2) Exclusion of confidential and/or competitively sensitive information relating to the Licensor, the Licensee or certain terms of the License Agreement. Omitted information is the subject of a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been filed separately with the Securities and Exchange Commission.
shall furnish corrected copies of such Licensor Know How within [***** **** ****(3)] after receipt of Licensee s written notice hereunder. Licensor shall use Commercially Reasonable Efforts to answer all questions received from Licensee regarding the Licensor Know How as soon as reasonably practicable after receipt.
2.5 Licensor shall execute all documents, give all declarations regarding the licenses granted hereunder and reasonably cooperate with Licensee at the costs of Licensee to the extent such documents, declarations and/or cooperation are required for the recordal or registration of the licenses granted hereunder at the various patent offices in the Territory for the benefit of Licensee.
2.6 Without limiting the generality of Section 2 hereof, Licensee specifically acknowledges and agrees that the license granted to Licensee hereunder shall be only for the Development, Manufacturing and Commercialization of Perifosine and/or Licensed Products in the Field within the Territory, and subject to any mandatory legal provisions which may apply and Section 9, Licensee shall not Develop, Manufacture, Commercialize Perifosine and/or Licensed Products for any other application or purpose whatsoever, and shall not actively promote, or solicit orders for the sale of the Licensed Products outside of the Territory, without the prior written authorization of Licensor, which Licensor may grant or withhold in its sole discretion.
3. Licensee s Obligations
3.1 Licensee shall use, and/or shall cause its Affiliates and/or sublicensees to use Commercially Reasonable Efforts to Develop, Manufacture, and Commercialize the Licensed Products in the Territory for the indications CRC and MM, in order to maximize the Net Sales derived from the Licensed Products throughout the continuance of this Agreement. In particular, Licensee shall use, and/or shall cause its Affiliates and/or sublicensees to use Commercially Reasonable Efforts to:
(i) Develop the Licensed Products for the indications CRC and MM and for the Territory in accordance with the Development Plan and not terminate or halt such Development, unless there are substantial safety, efficacy, commercial or regulatory reasons for doing so, and full details of such reasons have been notified to Licensor in writing;
(ii) apply for and obtain all required Regulatory Approvals in the Territory following successful completion of all appropriate clinical trials;
(iii) make the First Commercial Sale of the Licensed Products in the Territory within [**** *** *****] following the issuance of the NHI Drug Price for the first Licensed Product by Regulatory Authorities in the Territory;
(iv) maintain an adequate sales force and provide for relevant staff to manage the pre- and post-launch activities required to market the Licensed Products in the Territory;
(3) Exclusion of confidential and/or competitively sensitive information relating to the Licensor, the Licensee or certain terms of the License Agreement. Omitted information is the subject of a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been filed separately with the Securities and Exchange Commission.
(v) seek to maximize sales of the Licensed Products for the indications CRC and MM in the Territory; and
(vi) [*******************************************(4)].
3.2 Subject to Licensor s prior written consent which shall not be unreasonably withheld, Licensee, its Affiliates and/or sublicensees may conduct clinical trials outside the Territory for obtaining Regulatory Approvals in the Territory. Without limiting the foregoing, Licensee, its Affiliates and/or sublicensees shall not conduct any clinical trials outside the Territory which are reasonably expected to adversely affect Licensor s, its Affiliates or Licensor s Other Licensees activities to apply for and obtain Regulatory Approvals outside the Territory.
3.3 Licensee, its Affiliates and/or sublicensees shall be solely responsible for all regulatory filings and submissions for Regulatory Approvals as well as any related regulatory pre-submission and post-submission activities (including, but not limited to, pre-submission meetings, letters of intent, paediatric investigation plans and trademark approval) with respect to of the Licensed Products in the Territory (including, without limitation, obtaining all Regulatory Approvals required to sell the Licensed Products in the Territory) and shall bear all costs in connection with the filing and conduct of the submissions. Following submission, Licensee, its Affiliates and/or sublicensees at its cost, but with support as reasonably necessary from Licensor, will be responsible for all regulatory activities, regulatory reporting and maintenance requirements and medical information services, in each case relating to the Licensed Products in the Territory. Licensee, its Affiliates and/or sublicensees will be the sole interface with and otherwise handle all correspondence, meetings and other interactions with the relevant Regulatory Authorities concerning the Regulatory Approvals of the Licensed Products in the Territory. All Regulatory Approvals in the Territory will be held in the name of Licensee or an Affiliate or sublicensee of Licensee.
3.4 After the First Commercial Sale in the Territory, Licensee shall furnish Licensor with quarterly reports of all of Licensee s sales of Licensed Products under this Agreement. Each such quarterly report shall (i) be furnished to Licensor within [****** *** ] after the close of the [** ] to which it corresponds; and (ii) state Licensee s total sales of the Licensed Products by Licensee, its Affiliates and sublicensees in the Territory, during the [ *******], the Net Sales derived by Licensee, its Affiliates and sublicensees from such sales, and the royalties payable by Licensee to Licensor with respect to such Net Sales pursuant to Section 5.4 of this Agreement.
In addition, commencing on the first April 1 following the date of the First Commercial Sale in the Territory, Licensee shall provide Licensor on or before April
(4) Exclusion of confidential and/or competitively sensitive information relating to the Licensor, the Licensee or certain terms of the License Agreement. Omitted information is the subject of a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been filed separately with the Securities and Exchange Commission.
1 in each Licensee s fiscal year with an [******* ** *** ********* *********(5)] in the Territory for the current Licensee s fiscal year.
3.5 If a Regulatory Authority desires to conduct an inspection or audit with regard to the Licensed Product of Licensee s, its Affiliates facility or sublicensee s facility or facility of the other Third Party under contract with Licensee, its Affiliates or its sublicensees, Licensee shall permit and cooperate with such inspection or audit, and shall cause its Affiliates, its sublicensees or the contracted Third Party to permit and cooperate with such Regulatory Authority and Lisensor during such inspection or audit, provided, however, that such inspection or audit shall not unreasonably interfere with operations at the facility. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which Licensee shall immediately provide to Licensor), Licensee shall, or shall cause its Affiliates, its sublicensees or the contract facility to, prepare the response to any such observations, and provide a copy of such response to Licensor that has been translated into English. Licensee agrees to, or causes its Affiliates, its sublicensees or the contract facility to, conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in a good faith that such commitments violate applicable laws and/or regulations.
4. Licensor s Obligations
4.1 Licensor shall use, and/or shall cause its Affiliates and/or Licensor s Other Licensees to use Commercially Reasonable Efforts to Develop, Manufacture and Commercialize the Licensed Products outside the Territory for the indications CRC and MM. In particular, Licensor shall use, and/or shall cause its Affiliates and/or Licensor s Other Licensees Date to use Commercially Reasonable Efforts to:
(i) Develop or have Developed the Licensed Products for the indications CRC and MM for outside the Territory and not terminate or halt such Development unless there are substantial safety, efficacy, commercial or regulatory reasons for doing so, and full details of such reasons have been notified to Licensee in writing;
(ii) promote the distribution of Licensed Products for the indications CRC and MM and maximize sales of such Licensed Products outside the Territory;
(iii) maintain stable supply of Perifosine, Trial Products, and/or Licensed Products in semi-finished form (only applicable to Licensor); and
(iv) apply for and obtain all required Regulatory Approval for Licensed Products for the indications CRC and MM outside the Territory following successful completion of all appropriate clinical trials.
[******************************************]
(5) Exclusion of confidential and/or competitively sensitive information relating to the Licensor, the Licensee or certain terms of the License Agreement. Omitted information is the subject of a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been filed separately with the Securities and Exchange Commission.
4.2 Licensor shall permit, or cause its Affiliates and/or Third Party manufacturer to permit, on reasonable prior written notice and not more often than [**** ***(6)] every year except where required by applicable laws, Licensee or a Regulatory Authority to inspect the facility of Licensor, Licensor s Affiliates and/or any Third Party manufacturer under contract with Licensor and/or its Affiliates, provided, however, that such inspection shall not unreasonably interfere with operations at the facility and it being understood by Licensee that Licensor shall have the right to coordinate any such inspection with Licensor s Other Licensees. Licensor shall cooperate with Licensee and/or such Regulatory Authority during such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which Licensor shall immediately provide to Licensee), Licensor shall, or shall cause its Affiliates or Licensor s Other Licensees or the contracted Third Party to, prepare the response to any such observations, and shall provide a copy of such response to Licensee in English. Licensor agrees to, or causes its Affiliates or Licensor s Other Licensees or the contract facility to, conform its activities with regard to the Licensed Product to any commitments made in such a response, except to the extent such commitments violate applicable laws and/or regulations.
5. Payments and Royalties
5.1 In consideration for the rights and licenses granted by Licensor to Licensee under this Agreement, Licensee shall pay to Licensor the lump sum amount of Six Million EURO ( 6,000,000) within [******** **** ****] after the Effective Date.
5.2 In addition to the lump sum payment specified in Section 5.1 hereof and as further consideration for the rights and licenses granted by Licensor to Licensee under this Agreement, Licensee shall make the following milestone payments to Licensor:
(i) upon the first patient enrollment of the first clinical trial conducted by or on behalf of Licensee, its Affiliates or sublicensees regarding Licensed Products:
[*** ] EURO ( [**]); and
(ii) upon the first submission for Marketing Authorization regarding Licensed Products for CRC in the Territory:
[***** ] EURO ( [**]); and
(iii) upon the first grant of Marketing Authorization regarding Licensed Products for CRC in the Territory:
[***** ] EURO ( [**]); and
(iv) upon the first submission for Marketing Authorization regarding Licensed Products for MM in the Territory:
(6) Exclusion of confidential and/or competitively sensitive information relating to the Licensor, the Licensee or certain terms of the License Agreement. Omitted information is the subject of a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been filed separately with the Securities and Exchange Commission.